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Other-Sonic Generic Ultrasound Transmission Gel

Recall for specific lots

7 June 2012

Specific lots of Other-Sonic Generic Ultrasound Transmission Gel have been recalled due to contamination by bacteria. These lots were manufactured between June and December 2011 by Pharmaceutical Innovations Inc, USA.

Contamination has been found in lot numbers 060111, 090111 and 081411. This gel has been sold in Australia by a number of sponsors.

Health professionals should stop using these products immediately and patients concerned about exposure to this product should seek advice from their GP.

Information for health professionals

Health professionals should ensure that products with these lot numbers are no longer used, and where possible identify patients who have come into contact with the contaminated lots. Please note that you cannot identify contaminated products by looking at the gel.

Do not use Other-Sonic Generic Ultrasound Transmission Gel with lot numbers 060111, 090111 and 081411. These lots come in both 250 ml and 5 L containers.

Where possible identify patients who have been exposed to these lots of Other-Sonic Generic Ultrasound Transmission Gel. Review the procedures they underwent and the outcomes of the procedures, and take further action as necessary.

Quarantine unopened product for return to the supplier when requested. Australian sponsors have been contacted by the TGA and are working with the TGA to recall affected products.

Dispose of all opened containers by following your facility's procedure for disposing of bio-hazardous materials.

Clean all reusable equipment according to the manufacturer's instructions. Do not reuse single use equipment.

Please ensure that for procedures that require the use of sterile gel, you use only unopened containers labelled 'sterile'.

Information for patients

There is a small risk that patients who have been exposed to contaminated Other-Sonic Generic Ultrasound Transmission Gel may develop infection due to the contaminant in the area where the gel was used. If you are concerned about having been exposed to the contaminated gel, consult your GP, especially if you are showing signs of infection.

Ultrasonic gel is used when an ultrasound procedure is undertaken. Ultrasounds are used in many different medical situations including:

accident and emergency,

chiropractic,

diagnostic imaging,

gastroenterology,

obstetrics and gynaecology,

physiotherapy, and

urology.

About the bacterial contamination

The TGA has confirmed the presence of the bacteria Klebsiella oxytoca and Pseudomonas aeruginosa in samples taken from the contaminated lots.

Klebsiella oxytoca is widespread in the environment. Clinical conditions caused by local exposure to this organism include skin, soft tissue or wound infections, and urinary tract infections (UTIs). In addition this organism may cause cholecystitis, diarrhoea, upper respiratory tract infection, thrombophlebitis, osteomyelitis, pneumonia, meningitis and septicaemia.

Pseudomonas aeruginosa is also widespread in the environment. Clinical conditions caused by this organism include wound and soft tissue infections, and urinary tract infections (UTIs). In addition this organism may cause gastrointestinal infections, osteomyelitis, pneumonia, septicaemia and meningitis.

The TGA cannot give personal advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.